Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy

Ankylosing Spondylitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517620
• Other study ID #: [2011]2-38
• Status: Completed
• Phase: Phase 4
• First received: January 15, 2012
• Last updated: December 12, 2013
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: December 2013
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomized, open-label clinical trial to evaluate the efficacy and safety of total glucosides paeony capsules in maintaining clinical remission in patients with ankylosing spondylitis which achieved clinical remission after anti-TNF therapy. Patients will be divided into two groups randomly, one group receive non-steroid anti-inflammatory drugs(NSAID) mono-therapy and the other group receive total glucosides paeony capsules plus NSAID therapy for 24 weeks. The primary clinical endpoint is the proportion of patients which disease activity reaches relapse criteria. The investigator's hypothesis the proportion of relapse in total glucosides paeony capsules plus NSAID group would be lower than the NSAID mono-therapy group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged from 16-65 years, sign the Informed Consent

• Fulfill 1984 modified NewYork classification criteria for AS

• Achieved clinical remission after at least 12 weeks' therapy of anti-TNF therapy

• Hb=9g/dl, ALT/AST= 2 folds of upper level normal range, creatine=120mol/L(=1.4mg/dl)

• Commitment to contraceptive for woman

Exclusion Criteria:

• History of psoriasis and/or inflammatory bowel diseases

• Receive intra-articular injection of cortisone within 3 months before enrollment

• History of the listed diseases: heart failure, Multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis

• Pregnant and lactating women

• Mentally ill, Alcoholics and drug addicts

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Total Glucosides Paeony Capsules
Total Glucosides Paeony Capsules, oral, 0.3 gram per capsule, 3 capsules tid, 24 weeks

Locations

Country	Name	City	State
China	Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of patients which disease activity reaches relapse criteria		24 weeks	No
Secondary	BASDAI score comparing to baseline		24 weeks	No
Secondary	BASFI score comparing to baseline		24 weeks	No